NErve Rootblock VErsus Surgery: NERVES

Conditions

Acute sciatica secondary to prolapsed intervertebral disc Musculoskeletal Diseases Sciatica

Martin Wilby, Ashley Best, Eifiona Wood, Girvan Burnside, Emma Bedson et al. (19 authors)

Health Technology Assessment2021-04-0110 citations

Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a phase 3, multicentre, open-label, randomised controlled trial and economic evaluation.

Wilby MJ, Wilby MJ, Best A, Wood E, Burnside G, Bedson E, Short H, Wheatley D, Hill-McManus D, Sharma M, Clark S, Baranidharan G, Price C, Mannion R, Hutchinson PJ, Hughes DA, Marson A, Williamson PR.

2021-03-1840 citations

10.1016/s2665-9913(21)00036-9

Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial.

Wilby MJ, Wilby MJ, Hopkins C, Bedson E, Howlin S, Burnside G, Conroy EJ, Hughes DA, Sharma M, Marson A, Clark SR, Williamson P.

2018-09-056 citations

10.1186/s13063-018-2677-5

Interventions

The technologies to be compared are: 1. Fluoroscopically guided trans-foraminal epidural steroid injection (TFESI) of a standard combination of local anaesthetic and steroid drug and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: As of 19/05/2016: 1. Diagnosed lower extremity radiculopathy (sciatica) 2. Sciatica secondary to prolapsed intervertebral disc (PID) (proven on MRI) 3. Duration of symptoms between 6 weeks and 12 months 4. Leg pain non-responsive to conservative, non-invasive management 5. Age 16 – 65 years 6. Patient has attempted at least one form of conservative (non-operative) treatment* but this has not provided adequate relief of patient’s pain/symptoms 7. Patient willing and able to give consent *including but not limited to; medication, physiotherapy, modification of daily activities Previous inclusion criteria: 1. Newly diagnosed disabling sciatica secondary to prolapsed intervertebral disc (proven on MRI) 2. Duration of symptoms between 6 weeks and 6 months 3. Failed conservative, non-invasive management 4. Age over 16 years 5. Diagnosed with lower extremity radiculopathy (sciatica) secondary to a lumbar disc herniation 6. Medication has not been helpful in treating the patient's pain/symptoms 7. Modification of daily activities has not been helpful in treating the patient's pain/symptoms 8. Physiotherapy has not been helpful in treating the patient's pain/symptoms 9. Patient willing to give consent

Exclusion criteria

Exclusion criteria: As of 19/05/2016: 1. Serious neurological deficit (e.g. foot-drop/possible cauda-equina compression) 2. Previous spinal surgery at the same intervertebral disc (level) 3. Sciatica presentation for longer than 12 months 4. Age 65 6. Patient has not attempted any form of conservative treatment 7. Any patient who has a contraindication for surgery and/or injection 8. Patient known to be pregnant Previous exclusion criteria: 1. Neurological deficit (foot-drop/possible cauda-equina compression) 2. Previous surgery at that level 3. Age: < 16 4. Any patient who has not attempted conservative non-operative treatment for a minimum of 6 weeks 5. Any patient who has a contraindication for surgery 6. Any patient who is pregnant

Design outcomes

Primary

Measure	Time frame
Pilot Study (recruitment from 2 sites for 6 months): Predicted full trial recruitment period 40% Full study: Oswestry Disability Questionnaire (ODQ; a condition specific outcome measure with over 30 years of scientific validation) at 3 months post-intervention	—

Secondary

Measure	Time frame
1. ODQ at 6 months post intervention 2. ODQ at 9 months post intervention 3. ODQ at 12 months post intervention 4. Visual analogue pain scores for leg and back pain 5. Likert Scale 6. Modified Roland-Morris outcome scale for sciatica 7. Core Outcome Measures Index (COMI) 8. Work status (return to work) 9. QOL 10. Health economic outcomes expressed as the incremental cost per quality-adjusted life-year (QALY)	—

Measure

Time frame

1. ODQ at 6 months post intervention 2. ODQ at 9 months post intervention 3. ODQ at 12 months post intervention 4. Visual analogue pain scores for leg and back pain 5. Likert Scale 6. Modified Roland-Morris outcome scale for sciatica 7. Core Outcome Measures Index (COMI) 8. Work status (return to work) 9. QOL 10. Health economic outcomes expressed as the incremental cost per quality-adjusted life-year (QALY)

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Countries

United Kingdom

Outcome results

None listed